Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04770337 |
Recruitment Status :
Recruiting
First Posted : February 25, 2021
Last Update Posted : December 20, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractory Epilepsy Focal Seizure Seizures, Focal Seizures Epilepsy in Children Epilepsy Epilepsy, Tonic-Clonic | Device: STARSTIM device Device: Sham Device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 190 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | multiple site, randomized, double blinded parallel-group controlled study |
Masking: | Double (Participant, Investigator) |
Masking Description: | Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject shall be notified of the treatment assignment. |
Primary Purpose: | Treatment |
Official Title: | STARSTIM: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY |
Actual Study Start Date : | October 25, 2021 |
Estimated Primary Completion Date : | October 2023 |
Estimated Study Completion Date : | October 2024 |

Arm | Intervention/treatment |
---|---|
Sham Comparator: Sham treatment
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
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Device: Sham Device
Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp |
Experimental: STARSTIM device treatment
Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.
|
Device: STARSTIM device
Cathodal Transcranial Direct Current Stimulation (tDCS). Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp. |
- The difference between active treatment and sham treatment in the percentage change [ Time Frame: from baseline in seizures over the 12 weeks following initiation of treatment. ]
- The proportion of subjects who are responders (defined as subjects with a 50% or greater reduction in seizure frequency [ Time Frame: from baseline to week 12 post-treatment ]

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Ages Eligible for Study: | 9 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 9 years old or older
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Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures.
Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization.
- Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure control despite demonstrated compliance, according to medical records, on at least two (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's demographic according to package labeling, within approximately the last 3 years.
- Seizure frequency ≥3 per month, over the past year.
- Currently on ≥1 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior to baseline visit in the study and no planned dose changes during the trial. Changes after baseline visit are permitted only if clinically necessary.
- An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR sequences, performed within past 3 years and more recently than any craniotomy or skull burr hole procedure.
- Seizure focus that allows design of an appropriate stimulation montage. Note: Seizure focus can be identified within a lobe, or 2 adjacent lobes. Identification of the border of the seizure focus can be approximate (+/- 2 gyri).
- Available seizure history and supporting data
- All female study subjects of child-bearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control (defined as having a documented failure rate of <=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as effective).
- Written informed consent obtained from study subject or subject's legal representative and ability for study subject to comply with the requirements of the study.
- Assent from pediatric subjects when appropriate.
Exclusion Criteria:
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data.
- Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is defined as a cortical region confined to one hemisphere and either one lobe or on a junction of two adjacent lobes from which seizures arise , as documented by scalp or intracranial EEG, that is either supported or not refuted by MRI, and either supported or not refuted by clinical semiology). If the interictal EEG is normal, a seizure focus may be identified by the combination of structural findings on MRI and clinical signs/symptoms associated with the subject's seizures.
- Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal
- Seizure focus is hemispheric or poorly defined
- History of psychogenic nonepileptic seizures in past 2 years, or physiologic nonepileptic seizures and non-epileptogenic events, including suspicion for or a significant history of syncope, and any non-epileptic events must be clearly differentiable from subject's focal seizures based on previously recorded video EEG showing distinct clinical and electrographic features of the subject's PNES compared to their epileptic seizures.
- Seizures of generalized onset
- Status epilepticus in the last 12 months
- Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise interfere, limit, affect or reduce the subject's ability to complete a study of 24 weeks duration
- Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may adversely impact the safety of the subject or the integrity of the data.
- Damaged skin on scalp that may interfere with tDCS stimulation.
- Pregnant or unwilling to practice birth control during participation in the study.
- Nursing mothers.
- Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant). Note: Vagus nerve stimulator (VNS) is allowable if the device is in MR Mode (e.g. switched off) during tDCS stimulation and the VNS device is MR conditional.
- Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
- A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use of any illicit substance.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770337
Contact: Demi Thai, M.D | demi.thai@neuroelectrics.com | ||
Contact: Thaïs Baleeiro, PhD | +34 93 254 03 66 | thais.baleeiro@neuroelectrics.com |
United States, California | |
Loma Linda University Health | Recruiting |
Loma Linda, California, United States, 92354 | |
Contact: Danilo Vitorovic, M.D dvitorovic@llu.edu | |
Contact: Julie Lacanlale, CRC (909) 558-2037 JLacanlale@llu.edu | |
Keck Medicine of USC | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Charles Liu, M.D cliu@usc.edu | |
Contact: Joanne Gibbons, CRC (818) 284-1626 joannegi@med.usc.edu | |
United States, Florida | |
University of Florida Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32209 | |
Contact: Katherine Zarroli, M.D katherine.zarroli@jax.ufl.edu | |
Contact: Yasmeen Shabbir, CRC 904-244-9856 yasmeen.shabbir@jax.ufl.edu | |
United States, Maryland | |
LifeBridge Health | Recruiting |
Baltimore, Maryland, United States, 21215 | |
Contact: Arash Foroughi, M.D aforough@lifebridgehealth.org | |
Contact: Seanne Facho, CRC 410.601.0960 sfacho@lifebridgehealth.org | |
United States, Massachusetts | |
Boston Children's Hospital Comprehensive Epilepsy Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Alexander Rotenberg, M.D Alexander.Rotenberg@childrens.harvard.edu | |
Contact: Paul MacMullin, CRC (617) 355-7970 Paul.MacMullin@childrens.harvard.edu | |
Beth Israel Deconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Mo Shafi, M.D mshafi@bidmc.harvard.edu | |
Contact: Lucia Leblanc Perez, CRC 617-632-8934 lleblan1@bidmc.harvard.edu | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Brian Lundstrom, M.D lundstrom.brian@mayo.edu | |
Contact: Carey Huebert, CRC 507-293-1120 Huebert.Carey@mayo.edu | |
United States, Missouri | |
Washington University Medical Center | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Robert Hogan, M.D hoganre@wustl.edu | |
Contact: Patty Schaefer, CRC 314-362-7871 patty.schaefer@wustl.edu | |
United States, New Jersey | |
Robert Wood Johnson Medical School (Rutgers) | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Contact: Stephen Wong, M.D wongst@rwjms.rutgers.edu | |
Contact: Asha Cilly, CRC 732-235-7342 ac1659@rwjms.rutgers.edu | |
United States, New York | |
University of Rochester | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Trent Tollefson, M.D Trentton_Tollefson@urmc.rochester.edu | |
Contact: Noreen L Connolly, CRC (585) 275-0589 noreen_connolly@urmc.rochester.edu | |
United States, Pennsylvania | |
University of Pennsylvania (Penn Epilepsy) | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Mindy Ganguly, M.D taneeta.ganguly@pennmedicine.upenn.edu | |
Contact: Melissa Johnston Esparza, CRC (215) 662-7227 melissa.johnstonesparza@pennmedicine.upenn.edu | |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37212 | |
Contact: Abou-Khalil Bassel, M.D bassel.abou-khalil@vumc.org | |
Contact: Melissa Osborn, CRC 615-936-0209 melissa.osborn@vumc.org | |
United States, Utah | |
University Of Utah | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Amir Arain, M.D Amir.Arain@hsc.utah.edu | |
Contact: Laura Beeler, CRC (801) 585-9266 laura.beeler@hsc.utah.edu | |
United States, Washington | |
UW Valley Medical Center | Recruiting |
Renton, Washington, United States, 98055 | |
Contact: David Vossler, M.D david_vossler@valleymed.org | |
Contact: Shannon Huffaker, CRC (425) 690-3503 shannon_huffaker@valleymed.org | |
Seattle Children's Hospital, University of Washington | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Xiuhua Bozarth, M.D xiuhua.bozarth@seattlechildrens.org | |
Contact: Jackie Lee-Eng, CRC 12069872078 jacqueline.lee-eng@seattlechildrens.org |
Responsible Party: | Neuroelectrics Corporation |
ClinicalTrials.gov Identifier: | NCT04770337 |
Other Study ID Numbers: |
NE001 |
First Posted: | February 25, 2021 Key Record Dates |
Last Update Posted: | December 20, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Epilepsy Focal seizure Seizure |
Epilepsy Seizures Drug Resistant Epilepsy Epilepsies, Partial Epilepsy, Generalized |
Epilepsy, Tonic-Clonic Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations |